Kyprolis Patent Expiration

Kyprolis is a drug owned by Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc. It is protected by 12 US drug patents filed from 2013 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 27, 2033. Details of Kyprolis's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8207125 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US8207297 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US7232818 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US7417042 Compounds for enzyme inhibition
Jul, 2026

(2 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7491704 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US8207127 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US8129346 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US8207126 Compounds for enzyme inhibition
Apr, 2025

(8 months from now)

Active
US7737112 Composition for enzyme inhibition
Dec, 2027

(3 years from now)

Active
USRE47954 Combination therapy with peptide epoxyketones
Oct, 2029

(5 years from now)

Active
US9511109 Combination therapy with peptide epoxyketones
Oct, 2029

(5 years from now)

Active
US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same
Feb, 2033

(8 years from now)

Active


FDA has granted several exclusivities to Kyprolis. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kyprolis, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Kyprolis.

Exclusivity Information

Kyprolis holds 8 exclusivities. All of its exclusivities have expired in 2023. Details of Kyprolis's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 20, 2017
New Indication(I-712) Jul 24, 2018
New Indication(I-723) Jan 21, 2019
New Indication(I-722) Jan 21, 2019
Orphan Drug Exclusivity(ODE-27) Jul 20, 2019
Orphan Drug Exclusivity(ODE) Jul 20, 2019
New Dosing Schedule(D-172) Sep 28, 2021
New Indication(I-842) Aug 20, 2023

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US patents provide insights into the exclusivity only within the United States, but Kyprolis is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Kyprolis's family patents as well as insights into ongoing legal events on those patents.

Kyprolis's family patents

Kyprolis has patent protection in a total of 41 countries. It's US patent count contributes only to 26.7% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Kyprolis.

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Generic Launch

Generic Release Date:

Kyprolis's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 27, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Kyprolis Generics:

Carfilzomib is the generic name for the brand Kyprolis. 3 different companies have already filed for the generic of Kyprolis, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kyprolis's generic

How can I launch a generic of Kyprolis before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Kyprolis's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kyprolis's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Kyprolis -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
10 mg/vial 28 Nov, 2018 1 11 Jun, 2021 27 Feb, 2033 Deferred
60 mg/vial 20 Jul, 2016 9 09 Sep, 2019 07 Dec, 2027 Eligible
30 mg/vial 05 Oct, 2017 1 20 Mar, 2020 27 Feb, 2033 Eligible




About Kyprolis

Kyprolis is a drug owned by Onyx Pharmaceuticals Inc A Wholly Owned Sub Of Amgen Inc. It is used for treating relapsed or refractory multiple myeloma in patients who have received one to three lines of therapy. Kyprolis uses Carfilzomib as an active ingredient. Kyprolis was launched by Onyx Pharms Amgen in 2018.

Market Authorisation Date:

Kyprolis was approved by FDA for market use on 07 June, 2018.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Kyprolis is 07 June, 2018, its NCE-1 date is estimated to be 20 July, 2016

Active Ingredient:

Kyprolis uses Carfilzomib as the active ingredient. Check out other Drugs and Companies using Carfilzomib ingredient

Treatment:

Kyprolis is used for treating relapsed or refractory multiple myeloma in patients who have received one to three lines of therapy.

Dosage:

Kyprolis is available in powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
30MG/VIAL POWDER Prescription INTRAVENOUS
60MG/VIAL POWDER Prescription INTRAVENOUS
10MG/VIAL POWDER Prescription INTRAVENOUS